Smart Baby Monitor Effects on Infant Sleep and Parent Well-being
4 de septiembre de 2026 actualizado por: Udisense DBA Nanit
The NANIT Insights Study: Impact of Smart Baby Monitor Technology on Infant Sleep and Parental Well-being in First-Time Parents - A Randomized Controlled Trial
The goal of this clinical trial is to learn whether a smart baby monitor with full sleep analytics and behavioral guidance improves infant sleep and parent well-being in first-time parents during the first six months after birth.
The main questions it aims to answer are:
- Does access to Nanit's full monitoring features improve infant nighttime sleep - including total sleep time, bedtime consistency, nighttime awakenings, and how often parents need to intervene at night?
- Does it improve sleep quality and mental health outcomes for parents, including reduced postpartum depression and anxiety symptoms?
Researchers will compare families using the Nanit camera with full Milestone Insights features (sleep analytics, behavioral guidance, and developmental tracking) to families using the Nanit camera with live video only, to see whether the full suite of features leads to better sleep and well-being outcomes.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Estimado)
200
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Natalie Barnett, PhD
- Número de teléfono: +1 (866) 696-2648
- Correo electrónico: natalie.barnett@nanit.com
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10001
- Reclutamiento
- Nanit
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Contacto:
- Shambhavi Thakur
- Número de teléfono: 5512636389
- Correo electrónico: Shambhavithakur68@gmail.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Primary caregiver is biological parent
- Expecting first child (nulliparous)
- Currently between 34 weeks of gestation and end of gestation
- Primary caregiver aged 21 or older
- Access to a smartphone or tablet compatible with the Nanit application
- Able to complete study surveys in English
- Any family structure (single parent, coupled, same-sex couples, etc.)
Exclusion Criteria:
- Infant born prior to 35 weeks gestational age (preterm birth)
- Infant born with a severe medical condition requiring intensive neonatal care at time of study measures
- Multiple gestation (twins, triplets, or higher-order multiples)
- Prior children living in the household (not first-time parents)
- Primary caregiver works shift work or irregular schedules
- Primary caregiver diagnosed with a sleep disorder (OSA, RLS, PLMD, RBD, or other)
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Intervention Group - Nanit Full Features (Milestone Insights)
Participants in this arm receive a Nanit baby monitor camera with full access to the Nanit Milestone Insights subscription, including sleep analytics, behavioral guidance, developmental tracking, and all in-app features.
Participants use this as their primary baby monitor from enrollment through 6 months postpartum.
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A smart baby monitor camera providing live video streaming combined with full access to sleep analytics, behavioral guidance notifications, developmental milestone tracking, and in-app parenting tips via the Nanit mobile application.
Participants use the device as their primary infant monitor from birth through 6 months postpartum.
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Comparador activo: Control Group - Nanit Live Video Only
Participants in this arm receive a Nanit baby monitor camera with access to live video streaming only.
Sleep analytics, behavioral guidance, and developmental tracking features are disabled.
Participants use this as their primary baby monitor from enrollment through 6 months postpartum.
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A smart baby monitor camera providing live video streaming only.
Sleep analytics, behavioral guidance, developmental tracking, and in-app guidance features are disabled for the duration of the study.
Participants use the device as their primary infant monitor from birth through 6 months postpartum.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Infant Bedtime Variability
Periodo de tiempo: Month 4 and Month 6 postpartum
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Night-to-night consistency of infant bedtime measured objectively by the Nanit camera.
The bedtime variability is in minutes and higher variability shows worse outcome
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Month 4 and Month 6 postpartum
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Infant Nighttime Sleep Duration
Periodo de tiempo: Month 4 and Month 6 postpartum
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Total nighttime sleep duration measured objectively via the Nanit camera and parent-reported via the Brief Infant Sleep Questionnaire-Revised (BISQ-R).
Both are measured in minutes and higher score means better outcome
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Month 4 and Month 6 postpartum
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Infant Nighttime Awakenings
Periodo de tiempo: Month 4 and Month 6 postpartum
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Number of infant nighttime awakenings measured objectively by the Nanit camera and parent-reported via the Brief Infant Sleep Questionnaire-Revised (BISQ-R).
Measured in whole number, higher night awakenings show worse outcome
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Month 4 and Month 6 postpartum
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Parental Nighttime Interventions
Periodo de tiempo: Month 4 and Month 6 postpartum
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Number of times a parent intervenes in the infant's sleep during the night, measured objectively by the Nanit camera.
Measured in whole number, minimum 0 and higher interventions show worse outcome
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Month 4 and Month 6 postpartum
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Parental Sleep Quality
Periodo de tiempo: Baseline (third trimester), Month 4, and Month 6 postpartum
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Self-reported sleep quality for primary and secondary caregivers measured by the Pittsburgh Sleep Quality Index (PSQI). The scale is from 0-21, higher score shows worse outcome |
Baseline (third trimester), Month 4, and Month 6 postpartum
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Postpartum Depression Symptoms
Periodo de tiempo: Baseline (third trimester), Month 4, and Month 6 postpartum
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Self-reported postpartum depression symptoms for primary and secondary caregivers measured by the Edinburgh Postnatal Depression Scale (EPDS).
The range is 0 to 30.
Higher scores show worse outcome
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Baseline (third trimester), Month 4, and Month 6 postpartum
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Postpartum Anxiety Symptoms
Periodo de tiempo: Baseline (third trimester), Month 4, and Month 6 postpartum
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Self-reported postpartum anxiety symptoms for primary and secondary caregivers measured by the Edinburgh Postnatal Depression Scale (EPDS).
Measured on scale of 0-9.
Higher score shows worse outcome
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Baseline (third trimester), Month 4, and Month 6 postpartum
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Parenting Confidence and Self-Efficacy
Periodo de tiempo: Month 4 and Month 6 postpartum
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Self-reported parenting confidence and shared parental responsibility measured by the Parenting Confidence Scale (0 to 45), higher scores indicate greater parenting confidence and parental self-efficacy.
Shared Parental Responsibility Scale (14 to 70), The scale measures the relative division of labor between maternal and paternal roles rather than "good" or "bad" parenting.
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Month 4 and Month 6 postpartum
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Infant-Related Orthosomnia
Periodo de tiempo: Month 4 and Month 6 postpartum
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Parental preoccupation with infant sleep tracking data and its association with parental anxiety, measured by the infant-related orthosomnia survey.
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Month 4 and Month 6 postpartum
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Household Chaos
Periodo de tiempo: Month 4 and Month 6 postpartum
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Self-reported household disorganization and instability measured by the CHAOS scale on 0 to 15 score.
Higher score shows worse outcome
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Month 4 and Month 6 postpartum
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Postpartum Social Support
Periodo de tiempo: Month 4 and Month 6 postpartum
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Self-reported perceived social support measured by the Postpartum Social Support Questionnaire (PSSQ) on 50 to 350 score.
A higher score indicates a better outocme
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Month 4 and Month 6 postpartum
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Return-to-Work Productivity
Periodo de tiempo: Month 4 and Month 6 postpartum
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Self-reported workplace productivity and absenteeism following parental leave, measured by the workplace productivity and return-to-work survey.
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Month 4 and Month 6 postpartum
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Torticollis and Plagiocephaly Knowledge and Incidence
Periodo de tiempo: Baseline (third trimester) and Month 6 postpartum
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Parent-reported knowledge of torticollis and plagiocephaly and any infant diagnosis, assessed via survey.
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Baseline (third trimester) and Month 6 postpartum
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
15 de julio de 2026
Finalización primaria (Estimado)
15 de abril de 2027
Finalización del estudio (Estimado)
15 de abril de 2027
Fechas de registro del estudio
Enviado por primera vez
27 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
4 de septiembre de 2026
Publicado por primera vez (Actual)
10 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
4 de septiembre de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- Pro00094891
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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